Blood-Based Colorectal Cancer CRC Screening Market Likely to Benefit From FDA's Panel Surprise Advisory Possibility: Analyst

Tuesday, Guardant Health Inc GH announced that the FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is tentatively scheduled to review the premarket approval application (PMA) for its Shield blood test to screen for colorectal cancer on March 28, 2024. 

Guardant Health submitted the final module of its PMA for Shield on March 10, 2023. 

The submission includes data from the ECLIPSE study, an over 20,000-patient registrational study evaluating the performance of its blood test for detecting colorectal cancer in average-risk adults.

William Blair suggests that the recent news will likely favor the blood-based CRC screening market. 

This development stems from the panel's ability to analyze comprehensive data from the ECLIPSE study.

Additionally, this discussion is anticipated to offer crucial insights to the public regarding the panel's perception of the potential for tests like these.

Regarding Guardant shares, the analyst says the recent news is a surprise, considering that the management had indicated a lower likelihood of a panel based on submission timing. 

Despite the FDA's authority to call for an advisory panel at any point during the review process, the management had previously assessed the probability of this event as low due to the absence of a scheduled panel amidst the extended period post-submission.

William Blair estimates that Shield has no value associated with Guardant shares. It keeps the Outperform rating, driven by the current valuation (4.2 times 2024 revenue) and its strong positioning in the precision oncology segment.

Price Action: GH shares are down 7.60% at $25.78 on the last check Wednesday.